Javelin Pharmaceuticals Completes Subject Accrual For All Pharmacokinetic Clinical Studies Of PMI-150

Javelin Pharmaceuticals recently completed accrual of subjects in the last of four planned Phase 1 human pharmacokinetic (PK) studies needed to support its intended filing of a New Drug Application (NDA) next year for its intranasal ketamine product candidate, PMI-150.

This group of four PK studies enrolled a total of 151 subjects, of whom 139 received PMI-150 intranasally, 32 received intravenous ketamine, and 12 received oral ketamine. Some subjects received ketamine by more than one route of administration. No serious adverse events occurred in any of the four trials. Detailed analysis of the PK data is ongoing not simply for the NDA filing, but also for planned presentations at scientific and professional meetings and in the peer-reviewed literature.

"Timely completion of these trials keeps us on track for submission of the NDA for PMI-150," said Dr. Daniel Carr, CEO/CMO. "These studies did not involve patients in pain but instead were conducted in pain-free volunteers with the purpose of extending prior PK results. Their encouraging safety data adds to our already substantial safety database for this product candidate. Most importantly, these four PK studies comprise an integral part of our planned NDA submission because they provide essential dosing information for PMI-150," he added.

Dr. Curtis Wright, Javelin's Executive Vice President for Risk Management and Regulatory Affairs, commented, "This group of four PK studies addressed the multiple dose kinetics, the effects of common nasal decongestants and allergy medications, and the relative contributions of nasal and oral absorption to the bioavailability of PMI-150. As additional intranasal medications for systemic applications are developed, studies to evaluate how widely-used nasal medications affect (or not) the pharmacokinetics of a product are becoming more common. Completing these studies leaves us free to concentrate on our efficacy trial and start preparing modules for the NDA"

About Ketamine
Ketamine, a non-opioid, is an N-methyl-D-aspartate (NMDA) receptor antagonist that has been in clinical use for over 30 years. Since its approval by the FDA, ketamine has been safely used as an anesthetic in tens of thousands of patients. NMDA receptors are located in the central nervous system and play a role in the perception of acute and chronic pain. Ketamine, at lower doses than those approved for anesthetic use, has been reported in the medical literature to be an effective analgesic for post operative settings, nerve injury pain, and pain during medical procedures, such as burn dressing changes.

About PMI-150 (Intranasal Ketamine)
The Company is developing PMI-150, a proprietary nasal formulation of ketamine, for several intended indications. Javelin believes that PMI-150 is optimized for use as a pain medication and may offer a safe, non-opioid alternative for the treatment of acute moderate-to-severe pain. Prior randomized, double-blinded, placebo-controlled phase II clinical studies of PMI-150 have demonstrated rapid, statistically significant relief of moderate to severe postoperative and breakthrough pain. The Company is now planning a Pivotal Phase 3 postoperative acute pain study for this product candidate.

About Javelin Pharmaceuticals, Inc.
With corporate headquarters in Cambridge, MA, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market. The Company has three drug candidates in US Phase 3 clinical development. One of these US Phase 3 drug candidates, Dyloject, has received Marketing Authorization Application (MAA) approval and favorable pricing in the UK, where it is now being sold. Previous clinical trials have demonstrated its safety and rapid onset of action. For additional information about Javelin, please visit the company's website at www.javelinpharmaceuticals.com.

SOURCE: Javelin Pharmaceuticals, Inc.